Combination Chemotherapy With or Without Gemtuzumab Ozogamicin or Tipifarnib in Treating Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes
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|ClinicalTrials.gov Identifier: NCT00454480|
Recruitment Status : Completed
First Posted : March 30, 2007
Last Update Posted : August 26, 2013
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab ozogamicin, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with gemtuzumab ozogamicin or tipifarnib may kill more cancer cells.
PURPOSE: This randomized phase II/III trial is studying different combination chemotherapy regimens to compare how well they work when given with or without gemtuzumab ozogamicin or tipifarnib in treating patients with acute myeloid leukemia or high-risk myelodysplastic syndromes.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Myelodysplastic Syndromes||Biological: alemtuzumab Drug: arsenic trioxide Drug: azacitidine Drug: busulfan Drug: clofarabine Drug: cytarabine Drug: daunorubicin hydrochloride Drug: fludarabine phosphate Drug: gemtuzumab ozogamicin Drug: melphalan Drug: tipifarnib Genetic: DNA methylation analysis Genetic: cytogenetic analysis Genetic: gene expression analysis Genetic: mutation analysis Other: diagnostic laboratory biomarker analysis Other: immunologic technique Procedure: allogeneic hematopoietic stem cell transplantation Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|Official Title:||A Programme of Treatment Development for Older Patients With Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||August 2012|
- Overall survival
- Achievement of complete remission and reasons for failure
- Duration of remission, relapse rates, and deaths
- Hematological and nonhematological toxicity
- Supportive care requirements (and other aspects of health economics)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00454480
|Study Chair:||Alan K. Burnett, MD, FRCP||University Hospital of Wales|